Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TransCon IL-2 β/γ · 1 trial · 13 indications
Treatment emergent and treatment related adverse events (assessed by NCI CTCAE v5.0), serious adverse events (SAEs), adverse events leading to treatment discontinuation, deaths.
Determine the maximum tolerated dose by assessing the Incidence of Dose Limiting Toxicities (DLTs), treatment emergent and treatment related adverse events (assessed by NCI CTCAE v5.0), serious adverse events (SAEs), adverse events leading to treatment discontinuation and deaths.
To determine a recommended phase 2 dose of TransCon IL-2 β/γ and combination regimen for further development by evaluating number of patients with treatment-related adverse events as assessed by CTCAE.
| Arm | Type | Description |
|---|---|---|
| Part 1 Monotherapy Dose Escalation: TransCon IL-2 β/γ | EXPERIMENTAL | TransCon IL-2 β/γ in escalating doses to evaluate safety/tolerability and to determine the MTD and RP2D |
| Part 2 Combination Dose Escalation: TransCon IL-2 β/γ with Pembrolizumab | EXPERIMENTAL | TransCon IL-2 β/γ with Pembrolizumab in escalating doses to evaluate safety/tolerability and determine the MTD and RP2D |
| Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with SOC Chemo | EXPERIMENTAL | TransCon IL-2 β/γ using the RP2D with SOC Chemotherapy to evaluate safety/tolerability and anti-tumor activity of the combination |
| Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with TransCon TLR7/8 Agonist | EXPERIMENTAL | TransCon IL-2 β/γ with TransCon TLR7/8 Agonist using the RP2D to evaluate safety/tolerability and anti-tumor activity of the combination |
| Part 3 Monotherapy Dose Expansion: TransCon IL-2 β/γ followed by surgery | EXPERIMENTAL | (Optional Arm): TransCon IL-2 β/γ using the RP2D followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination |
| Part 3 Combination Dose Expansion: TransCon IL-2 β/γ with Pembrolizumab followed by surgery | EXPERIMENTAL | TransCon IL-2 β/γ using the RP2D with Pembrolizumab followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination |
| Part 3 Combination Dose Expansion:TransCon IL-2 β/γ with TransCon TLR7/8 Agonist followed by surgery | EXPERIMENTAL | TransCon IL-2 β/γ with TransCon TLR7/8 Agonist using the RP2D followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination |
| Part 3 Combination Dose Expansion:TransCon IL-2 β/γ + Pembrolizumab + SOC Chemo followed by surgery | EXPERIMENTAL | TransCon IL-2 β/γ using the RP2D with Pembrolizumab and SOC Chemotherapy followed by surgery to evaluate safety/tolerability and anti-tumor activity of the combination |
| Part 3 Combination Dose Expansion | EXPERIMENTAL | TransCon IL-2 β/γ + Pembrolizumab TransCon IL-2 β/γ using the RP2D with Pembrolizumab |
| Part 3 Combination Dose Expansion: TransCon IL-2 β/γ monotherapy | EXPERIMENTAL | TransCon IL-2 β/γ monotherapy |
| Part 3 Combination Dose Expansion: TransCon IL-2 β/γ + trastuzumab | EXPERIMENTAL | TransCon IL-2 β/γ + trastuzumab |
| Part 3 Combination Dose Expansion: TransCon IL-2 β/γ + trastuzumab emtansine (T-DM1) | EXPERIMENTAL | TransCon IL-2 β/γ + trastuzumab emtansine (T-DM1) |
| Part 4 Combination Dose Optimization | EXPERIMENTAL | TransCon IL-2 β/γ + Pembrolizumab TransCon IL-2 β/γ using the RP2D in titrating doses and/or different dose frequencies with Pembrolizumab |
| Name | Type | Description |
|---|---|---|
| TransCon IL-2 β/γ | DRUG | TransCon IL-2 β/γ will be administered as an intravenous (IV) infusion |
| Pembrolizumab | DRUG | Pembrolizumab will be administered as an intravenous (IV) infusion |
| Chemotherapy drug | DRUG | SOC chemotherapy will be administered as an intravenous (IV) infusion |
| TransCon TLR7/8 Agonist | DRUG | TransCon TLR7/8 Agonist will be administered as an IT (Intratumoral) injection |
| Surgery | PROCEDURE | Surgery will take place 4-6 weeks after last dose of study treatment. |
| Trastuzumab | DRUG | Trastuzumab will be administered as an intravenous (IV) infusion |
| Trastuzumab emtansine (T-DM1) | DRUG | Trastuzumab emtansine (T-DM1) will be administered as an intravenous (IV) infusion |
Key Inclusion Criteria: * At least 18 years of age, or country defined local legal age * Demonstrated adequate organ function at screening * Life expectancy \>12 weeks as determined by the Investigator * Female and male participants of childbearing potential who are sexually active must agree to us...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
TransCon IL-2 β/γ is an investigational oncology therapy being studied for the treatment of advanced solid tumors, including platinum-resistant ovarian cancer, post anti-PD-1 melanoma, cervical cancer, and non-small cell lung cancer. It is in Phase 1 clinical development for these indications.
TransCon IL-2 β/γ targets the IL2 receptor (IL2R). It is designed to modulate IL-2 signaling through the β/γ receptor complex, which is involved in activating immune cells such as T cells and natural killer cells in the tumor microenvironment.
TransCon IL-2 β/γ is being developed by Ascendis Pharma A/S, a biopharmaceutical company traded on the Nasdaq under the ticker symbol ASND. The company is conducting clinical trials to evaluate the drug's safety and tolerability in patients with advanced solid tumors.
TransCon IL-2 β/γ is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is active but not recruiting participants.
TransCon IL-2 β/γ is being studied in a Phase 1 clinical trial registered as NCT05081609. This trial investigates the drug alone or in combination with pembrolizumab and/or TransCon TLR7/8 agonist or other anticancer therapies in adults with locally advanced or metastatic solid tumors.
TransCon IL-2 β/γ is a specific form of TransCon IL-2 that selectively targets the β/γ receptor complex. It is distinct from other IL-2-based therapies that may engage the alpha receptor. The drug is being developed by Ascendis Pharma for oncology indications.